Quality Lead, Japan

Location Tokyo
Discipline Life Science
Job type Permanent
Salary Negotiatable
Reference 47342

 

Quality Lead

Key Responsibilities:

  • Audit Management – Host client audits and provide support for external inspections.

  • Quality Systems Oversight – Maintain, update, and ensure compliance with QMS policies.

  • Deviation Handling – Review and approve deviation investigations, ensuring proper resolution and documentation.

  • CAPA Management – Oversee corrective and preventive actions, ensuring effectiveness.

  • Regulatory Compliance – Ensure all quality processes align with local and global regulations.

  • Stakeholder Collaboration – Work closely with MI, operations, and client service teams.

  • Risk Management & Continuous Improvement – Identify potential risks, escalate concerns, and recommend corrective measures.

  • Committee Participation – Support regional and global quality committees.

  • Regional Quality Oversight – Serve as the primary quality contact for Japan, with potential for expanded responsibilities.

  • Administrative Support – Assist with documentation, reporting, and other quality-related tasks.

Required Qualifications:

  • Native Japanese speaker with strong English proficiency.

  • Experience hosting audits in a regulated industry.

  • In-depth knowledge of QMS, ideally with experience in electronic quality management systems (eQMS).

  • Extensive background in managing deviations and CAPAs, with authority to approve actions.

  • Strong organizational and communication skills, with the ability to manage quality-related challenges independently.

  • Previous experience in a pharmaceutical, medical device, or other regulated healthcare-related industry.